E-DRUG: Good or bad clinical practice? (cont)
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The Norwegian Medicines Control Authority started inspecting clinical
trials in April this year. The goal is to do about 10 inspections per year.
It will comprise physicians and dentists and also studies carried out by
contracting companies (CRO)
The objectives of the inspection will be to assess the ethical, scientific
and technical quality of the trial to ensure the safety and welfare of the
participating patients.
Kirsten
Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo, Norway
Tel: +47 22 56 05 85
myhr@online.no
[Is the Norwegian Authority also receiving the reports of the Monitors
and/or Auditors that are appointed and paid by the sponsor of a Clinical
Trial to assess the quality of the trial? In the UK, the Regulatory
Authority did not receive those reports. It is then difficult to know where
the problems are when deciding who to inspect. WB]
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